DA-2006P — Class III medical device recall Z-0457-2016
Terminated recall by BC Group International Inc, reported 2015-12-30, distributed nationwide. Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed re
| Recall number | Z-0457-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BC Group International Inc, Saint Charles, MO, United States |
| Recall initiated | 2015-10-28 |
| Classified | 2015-12-21 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2017-02-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 5 units |
Product
DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
Reason for recall
Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0457-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.